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Transfusion and treatment of severe anaemia in African children trial

TRansfusion and TReatment of severe Anaemia in African Children: a randomised controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84086586
Enrollment
3954
Registered
2013-02-11
Start date
2014-09-01
Completion date
Unknown
Last updated
2022-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe anaemia Haematological Disorders Nutritional anaemias

Interventions

The trial will have a factorial design with 3 randomisations, each to address one of the potential approaches to reducing mortality and morbidity in children with SA: R1: Immediate li

Sponsors

Imperial College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children will be recruited at the point of hospital admission 1. Aged 2 months to 12 years 2. Severe anaemia (SA) (Hb<6g/dl) within 2h of admission to hospital 3. Carer willing/able to provide consent

Exclusion criteria

Exclusion criteria: 1. Malignancy 2. Surgery 3. Acute trauma 4. Signs of bi-ventricular heart failure

Design outcomes

Secondary

MeasureTime frame
1. Mortality at 48 hours, 28 days, 90 day and 180 days (cumulative) (where not the primary outcome). 2. Morbidity: endpoints relating to the specific mechanisms of action of each intervention: 2.1. Re-admission to hospital 2.2. Proportion achieving correction of anaemia (defined by WHO as Hb>9g/dl) at 48 hours, 28 days, 90 day and 180 days 2.3. Development of new profound anaemia (Hb<4g/dl) during acute admission or development of severe anaemia (Hb<6g/dl) post discharge 3. Nutrition: changes in weight and MUAC at 90 day and 180 days 4. Anti-infection: changes in inflammatory markers (CRP, PCT), incidence of bacterial infections and malaria at 28 days, 90 day and 180 days

Primary

MeasureTime frame
Cumulative mortality to 4 weeks for the transfusion strategy comparison, and to 6 months for the nutritional support/antibiotic prophylaxis comparison

Countries

Malawi, Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026